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Argus Health
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Harvard Business School
Johnson and Johnson
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Dow
Federal Trade Commission
Deloitte
Cipla

Generated: January 21, 2019

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Bupropion hydrobromide - Generic Drug Details

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What are the generic drug sources for bupropion hydrobromide and what is the scope of bupropion hydrobromide patent protection?

Bupropion hydrobromide is the generic ingredient in one branded drug marketed by Valeant Pharms North and is included in one NDA. There are eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bupropion hydrobromide has fifty-one patent family members in seventeen countries.

There are thirty-eight drug master file entries for bupropion hydrobromide. One supplier is listed for this compound. There is one tentative approval for this compound.

Pharmacology for bupropion hydrobromide
Synonyms for bupropion hydrobromide
2-(tert-Butylamino)-1-(3-chlorophenyl)propan-1-one hydrobromide
2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one,hydrobromide
905818-69-1
AK-75761
AKOS015917698
Aplenzin
Aplenzin ER
bupropion HBr
Bupropion hydrobromide (USAN)
Bupropion hydrobromide [USAN]
CHEMBL1201735
D07938
I14-9201
SCHEMBL636116
WSTCENNATOVXKQ-UHFFFAOYSA-N
Tentative approvals for BUPROPION HYDROBROMIDE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial522MGTABLET, EXTENDED RELEASE; ORAL
➤ Try a Free Trial➤ Try a Free Trial174MGTABLET, EXTENDED RELEASE; ORAL

US Patents and Regulatory Information for bupropion hydrobromide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-003 Apr 23, 2008 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-002 Apr 23, 2008 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-003 Apr 23, 2008 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-002 Apr 23, 2008 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Valeant Pharms North APLENZIN bupropion hydrobromide TABLET, EXTENDED RELEASE;ORAL 022108-001 Apr 23, 2008 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for bupropion hydrobromide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB00/019 United Kingdom ➤ Try a Free Trial PRODUCT NAME: BUPROPION HYDROCHLORIDE; REGISTERED: NL RVG 24160 19991201; UK PL 10949/0340 20000607
/2000 Austria ➤ Try a Free Trial PRODUCT NAME: BUPROPION HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-23680 20000616; FIRST REGISTRATION: NL 24160 19991201
2017 00062 Denmark ➤ Try a Free Trial PRODUCT NAME: NALTREXON ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER NALTREXONHYDROCHLORID, OG BUPROPION ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, ISAER BUPROPIONHYDROCHLORID; REG. NO/DATE: EU/1/14/988 20150330
2017000109 Germany ➤ Try a Free Trial PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 20150326
2000 00018 Denmark ➤ Try a Free Trial PRODUCT NAME: BUPROPIONHYDROCHLORID; NAT. REG. NO/DATE: 31347 20000606; FIRST REG. NO/DATE: NL 24160 19991201
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
McKesson
Citi
Fuji
US Department of Justice
AstraZeneca
Julphar
Cipla

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